Analysis of trends and allergenicity risk assessments in novel food approvals within the European Union between 2018 and 2023

Novel food (NF) approvals in the European Union between 2018 and 2023 (n = 117) were retrieved and analysed. They consist of new NF (52.1%), modification (38.5%), and traditional food (9.4%). The average time taken for new NF applications to be approved was 38 months in 2023, with clock-stops occurring in all approvals since 2020. For new NFs, only 21.3% and 9.8% performed tests by bioinformatics homology and immunological analyses respectively, suggesting that allergenicity assessments remain a challenge. Allergenicity risks were regarded as possible for 47.5% of the new NF approvals, while 52.5% were expected to be low, very low, or unlikely. However, it was not always clear what the decision was based on. While protein intake levels were rarely mentioned in the allergenicity conclusions of approvals, new NFs with allergenicity risks typically had protein intake exceeding 1 mg/day. Establishing a dose that represents a Threshold of Allergological Concern below which a protein is unlikely to cause sensitisation in consumers, could make de novo allergenicity assessment of NFs more feasible. This approach might exempt certain proteins from testing, instead focusing on proteins of possible allergenic relevance.